China-based Innovent Biologics has entered into a strategic collaboration and license agreement with LG Chem Life Sciences, a unit of South Korea’s LG Chem, for the development of Tigulixostat.
Tigulixostat is a late-stage novel non-purine xanthine oxidase inhibitor (XOI) intended for the chronic management of hyperuricemia in patients with gout disease.
Under the terms of the agreement, the Chinese biopharmaceutical company will obtain an exclusive right to develop and commercialise Tigulixostat in China.
LG Chem will receive a total of up to $95.5m, which includes $10m in an upfront payment, milestones, plus tiered royalties on net sales of the product in the country.
LG Chem Life Sciences president Jeewoong Son said: “Tigulixostat will provide a better treatment option for gout patients in near future, and our collaboration with Innovent will accelerate the global development of Tigulixostat with the goal of bringing a potentially impactful treatment option to the patient with high unmet medical needs.
“We are very excited to enter into this strategic collaboration which is a major milestone for LG Chem as we are building global biotechnology and R&D capabilities, and hope to maximise the potential of Tigulixostat through this collaboration.
“We look forward to collaborating with Innovent to expedite the development of Tigulixostat and to commercialise the new XOI drug, based on the strong and broad experience and expertise of both companies.”
Tigulixostat has a different structure from other xanthine oxidase inhibitors and works by inhibiting the activity of xanthine oxidase to reduce the uric acid in purine metabolism.
The drug is currently being developed in the US and has shown adequate efficacy for sUA lowering and a good safety profile in a Phase 2 study.
After receiving FDA approval in June 2019, LG Chem commenced the Phase 2 clinical trial of Tigulixostat, dubbed CLUE study, in 156 gout patients at 42 clinical sites in the US.
In the CLUE study, Tigulixostat showed a superior dose-dependent reduction in sUA levels within two weeks, and the levels were well maintained throughout the study period.
The drug was well tolerated in gout patients at all dose levels compared to the placebo group, with no notable difference in the overall adverse events http://mirziamov.ru/zaym-bez-otkaza/ .
Innovent president Yong Jun Liu said: “As hyperuricemia and gout are both a rheumatic disease and a metabolic disease, the collaboration fits into Innovent’s strategic portfolio planning in rheumatic and metabolic areas, as well as creates great synergy with our current pipeline, development resources and commercial network.
“As one of the few next-generation XOI drugs in development, Tigulixostat has demonstrated higher efficacy compared to Febuxostat in exploratory analysis and a favourable safety profile in the phase 2 study, showing the great best-in-class potential in the treatment of gout.
“We will work closely with LG Chem to facilitate the development of Tigulixostat, and we hope to bring the novel product to the market as quickly as possible.”
Last year, Innovent signed an exclusive license agreement with AnHeart Therapeutics to co-develop and market the latter’s lead drug candidate, taletrectinib, in Greater China.
